AstraZeneca says two Phase 3 trials of Breztri Aerosphere MDI in uncontrolled asthma met their primary endpoints

According to AstraZeneca, the Phase 3 KALOS and LOGOS trials comparing Breztri (Trixeo) Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI to inhaled ICS/LABA in patients with uncontrolled asthma both met their primary endpoints. Breztri has been approved in the US for the treatment of COPD since July 2020 and is currently approved that indication in numerous countries including in the EU, China, and Japan.

The 24 – 52 week studies randomized approximately 4,400 patients and compared 320/28.8/9.6 μg and 320/14.4/9.6 μg doses of Breztri to PT009 budesonide / formoterol fumarate in an Aerosphere MDI and to Symbicort budesonide / formoterol MDI. Both studies demonstrated statistically significant change from baseline for Breztri in FEV1 area under the curve 0 to 3 hours at Week 24 and in trough FEV1 over 12-24 weeks and at Week 24, the company said.

AstraZeneca Executive VP, BioPharmaceuticals R&D, Sharon Barr commented, “We are excited by the positive results from the KALOS and LOGOS trials, which demonstrate that Breztri could help improve the lives of the millions of patients living with asthma. These asthma data build on the well-established profile of Breztri in COPD, and we look forward to sharing with regulatory authorities to bring this important medicine to a wider group of patients.”

In addition to developing Breztri for the expanded indication, AstraZeneca is also developing a version of the inhaler that uses HFO 1234ze(e) as the propellant. 

Read the AstraZeneca press release